IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 7 | Patient |
| 2024 | Obstruction/Occlusion | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Bacteremia | 1 | Patient |
| 2024 | Under-Sensing | 10 | Device |
| 2024 | Signal Artifact/Noise | 9 | Device |
| 2024 | Pacing Problem | 3 | Device |
| 2024 | Over-Sensing | 9 | Device |
| 2024 | Low impedance | 3 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Impedance Problem | 3 | Device |
| 2024 | High impedance | 3 | Device |
| 2024 | High Capture Threshold | 5 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device-Device Incompatibility | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2023 | Unspecified Infection | 13 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Dizziness | 2 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Bacteremia | 1 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Under-Sensing | 24 | Device |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Over-Sensing | 14 | Device |
| 2023 | Noise, Audible | 1 | Device |
| 2023 | Low impedance | 5 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 3 | Device |
| 2023 | High Capture Threshold | 14 | Device |
| 2023 | Fracture | 3 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 2 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Decreased Sensitivity | 3 | Device |
| 2023 | Crack | 1 | Device |
| 2023 | Break | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 7 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Shock from Patient Lead(s) | 1 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Insufficient Information | 3 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 2 | Patient |
| 2022 | Under-Sensing | 20 | Device |
| 2022 | Signal Artifact/Noise | 8 | Device |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Pocket Stimulation | 1 | Device |
| 2022 | Pacing Problem | 5 | Device |
| 2022 | Over-Sensing | 12 | Device |
| 2022 | Output Problem | 2 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Low impedance | 5 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2022 | Impedance Problem | 3 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | High Capture Threshold | 10 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Capture | 3 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 2 | Device |
| 2022 | Decreased Sensitivity | 3 | Device |
| 2022 | Capturing Problem | 2 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 3 | Device |
| 2022 | Ambient Noise Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Tachycardia | 2 | Patient |
| 2021 | Insufficient Information | 19 | Patient |
| 2021 | Bacterial Infection | 2 | Patient |
| 2021 | Appropriate Term / Code Not Available | 1 | Patient |
| 2021 | Unstable Capture Threshold | 1 | Device |
| 2021 | Under-Sensing | 7 | Device |
| 2021 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2021 | Signal Artifact/Noise | 7 | Device |
| 2021 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2021 | Over-Sensing | 7 | Device |
| 2021 | Low impedance | 1 | Device |
| 2021 | Insufficient Information | 8 | Device |
| 2021 | Impedance Problem | 3 | Device |
| 2021 | High impedance | 5 | Device |
| 2021 | High Capture Threshold | 8 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Failure to Capture | 4 | Device |
| 2021 | Electrical /Electronic Property Problem | 1 | Device |
| 2021 | Decreased Sensitivity | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Insufficient Information | 3 | Patient |
| 2020 | Atrial Fibrillation | 1 | Patient |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | Pocket Stimulation | 1 | Device |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Over-Sensing | 5 | Device |
| 2020 | Noise, Audible | 1 | Device |
| 2020 | Low impedance | 4 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Impedance Problem | 1 | Device |
| 2020 | Image Display Error/Artifact | 1 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | Failure to Capture | 2 | Device |
| 2020 | Electrical /Electronic Property Problem | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 2 | Device |
| 2020 | Ambient Noise Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |